CN108348749A

CN108348749A - Monitoring and stimulating module

Info

Publication number: CN108348749A
Application number: CN201680064445.3A
Authority: CN
Inventors: A·齐夫
Original assignee: Ziff Medical Co
Current assignee: Ziff Medical Co
Priority date: 2015-09-21
Filing date: 2016-09-20
Publication date: 2018-07-31
Anticipated expiration: 2036-09-20
Also published as: CN108348749B; JP7133469B2; BR112018006509A2; EP3352846A4; WO2017051408A1; US10632312B2; JP2018531125A; EP3352846B1; US20190001131A1; EP3352846A1

Abstract

Disclosed herein is the portable and integrated modules and device and its operating method of Noninvasive nerve modulation and monitoring for cardiac function.Module and device include that monitoring unit, electro photoluminescence induction unit and three electrodes are controllably used for the nerve modulation or monitoring of cardiac function so that one in electrode is difunctional.

Description

Monitoring and stimulating module

Technical field

Present disclosure is related to the field of the device for monitoring and handling cardiac parameters in some embodiments, and And more specifically but not exclusively to the wearable device for monitoring and handling cardiac parameters.

Background technology

Heart rate variability (HRV) refers to the variation of the time interval between normal cardiac activity (non-arrhythmia cordis heartbeat) Phenomenon.In normal healthy state, gradually the time interval between heartbeat can change during rest or in response to activity (such as being stood up by sitting posture) significantly changes, healthy and flexible phase between this instruction autonomic nerves system and cardiovascular system Mutually influence.Higher HRV parameters --- the such as gradually standard deviation (mark at the intervals NN of the time interval between normal cardiac activity Quasi- deviation or SDNN) and gradually the time interval between normal cardiac activity square average value square root (successive difference Root mean square or rMSSD) --- the preferable health of value instruction and peaceful and comfortable.The value of lower HRV parameters can indicate high pressure, Difference rest or sleep and certain pathological conditions.It is moving in body-building, higher HRV shows inductive education before exercise In preferably show.In cardiology, the patient with relatively low HRV after myocardial infarction shows with higher arrhythmia cordis Incidence and increased all-cause death rate.The Joint Task group of European Society of Cardiology and North America pace-making and electrophysiology meeting (joint taskforce)[Eu.Heart Journal.17,354-381；1996and Circulation Journal 1； 93(5):1043-65] it has issued and has emphasized that the guide of the importance of monitoring HRV is stated and outlines the improved clinical benefits of HRV. Some research reports [Circulation Journal.102:1239-1244,2000] it shows from 2 minutes rhythm and pace of moving things histograms The HRV measurements of (rhythm strip) are enough to determine increased cardiovascular morbidity and mortality risk.Other researchs have been reported Road [Journal of Cardiovascular Electrophysiology 25 (7):719-24；2014] HRV and the rhythm of the heart Substantial connection between not normal such as auricular fibrillation (AF) and monitoring HRV is highlighted to preventing the importance of arrhythmia cordis.

Nerve modulation --- i.e. nerve stimulation --- can be used to treat various diseases, and range such as presses down from phrenoblabia It is strongly fragrant to physiological condition such as chronic ache.Specifically, the nerve modulation of peripheral nerve can be used to adjust for autonomic nerve System.For example, the nerve modulation of median nerve and ulnar nerve can be used to enhance vagal parasympathetic nerve in forearm Activity and the cardiac nervous sympathetic nerve activity of compacting, and to reduce heart rate, cardiac rhythm is adjusted, and correct and prevent the heart It restrains not normal.The nerve modulation of median nerve and ulnar nerve may be utilized for inducing neural hormone response：It secretes endorphin, reduce Pressure correlation hormone, and sleep to reduce pressure and improve.

Mancarried device for monitoring and treating a variety of physiological conditions allows real-time treatment, no matter in response to acute danger As, or realize general health status and improved mood.Consumer wearable device had been seen in recent years --- it is designed as Physiological condition is monitored, from the device of tracking vital sign such as heart rate or blood pressure is designed as to recreational wearable device, than As wearable body-building tracker --- number steeply rises.Many in these devices is intended to monitor and is not designed to carry For treatment.Specifically, it is used to monitor many wearable devices of cardiomotility and function (such as heart rate, HRV) in the market --- It is no matter therapeutical or recreational --- treatment is not provided.

Invention content

This disclosure relates to the mancarried devices for monitoring and/or treating physiologic function.More specifically, the disclosure The aspect of content is related to following wearable device in some embodiments：It is used to monitor and/or influence cardiac function, And for influencing neurohormone balance and autonomic nerves system control and to influence heart rate, cardiac rhythm, heart rate variability (HRV) and holistic health.

As mentioned above, treatment is not provided for monitoring many commercialization mancarried devices of cardiac function.In response to It may be most important that the suddenly change of the cardiomotility of monitoring, which provides instant on-scene care in the case of acute cardiac crisis, , even if the device is only capable of providing initial treatment, must continued access complex treatment, such as within the hospital.Therefore, to as follows Wearable medical treatment device, which exists, to be needed：It has the residential care ability for providing continuous monitoring and customary prophylactic treatment, in list Stimulation and monitoring capability are provided in a device, advantageously allow for closed circuit (closed-loop) operation it is expected Therapeutic efficiency.Except medical application, cardiac function, and enhancing nerve-cardiovascular system phase can be monitored and treated The wearable device of interaction can also have following effectiveness：(a) as health auxiliary (aid), this is because above mentioned Correlation between cardiomotility and health status, and (b) body-building is used as to assist, allow user in the physical training period (session) influence its cardiomotility and HRV before and after, during, for example, with improve athletic performance and restore and thus Reduce injured possibility and the whole exercise performance of enhancing and target.It, can be based on obtaining recently according to some embodiments Measurement data adjusts stimulation parameter, in order to provide quick regulating loop, and is also based on the history of the measurement data of acquisition It is adjusted, in order to provide long-term circuit.

Thus, the aspect of present disclosure in some embodiments described herein, including is used to monitor and treat the heart The small and portable module of dirty function.The module can be used to measure heart rate, HRV and the electrocardiography for implementing user's heart Art (ECG), and the therefore value of cardiac parameters based on monitoring, provide the low of one or more peripheral nerves such as median nerve Horizontal electro photoluminescence is balanced with adjusting heart rate, cardiac rhythm and improving HRV and optimize nerve-heart.In addition, the module can be with It is used for health purpose, for example, sleeping to reduce pressure and improve.

Advantageously, not by unique and individual unit in module but by individual unit implement monitoring and treatment, For this meaning, module is integrated.Individual unit has conjugative component, be used to implement both monitoring and treatment, To save space and reduce the whole size of module.Specifically, module includes at least one bifunctional electrodes, be used to supervise Survey both cardiac parameters and electric nerve-stimulation.

In some embodiments, module can be independent, for example, in the form of wearable element, for example be designed as The band worn on wrist, arm, forearm, neck, leg and/or thigh.In some embodiments, can be designed as can be attached for module It is connected to intelligent wearable device such as smartwatch or intelligence band (smart-band) (and dismountable from its), or can be designed For the integration section of intelligent wearable device.Latter two embodiment can contribute to design as follows：Wherein module is used and is integrated to The component of intelligent wearable device, such as user interface, display, wireless communication unit, battery or even computing element (such as are located Manage device), to further decrease the size of module.

Module, module can also be used to be configured as transmission/reception together with the smart mobile phone of external device (ED) such as user From the information of external device (ED).Can be comprised the steps of according to the Exemplary neural instructed herein-stimulation period (using module into Row)：(a) electric signal of instruction cardiac function/activity such as HRV is measured, (b) smart mobile phone of transmission measurement data to user, Wherein processing measurement data (c) receives parameters of electrical stimulation and (is sent out by smart mobile phone to obtain the parameters of electrical stimulation for then treating Send), and nerve-stimulation (d) is applied according to the parameters of electrical stimulation of acquisition.

Thus, according to the aspect of some embodiments, provide one or more outer for Non-Invasive electric nerve-stimulation The portable module of all nerves and one or more cardiac parameters of monitoring object.Portable module includes：

Electrode is monitored, be mounted in the top surface of portable module/on；

Stimulating electrode and bifunctional electrodes, be mounted in the bottom surface of portable module/on；

Monitoring unit is used to monitor electrical activity；

Stimulating unit is used to induce electric signal；With

Control unit；

Non-transitory memory has the computer-readable generation for being configured to be operated by control unit stored wherein Code.

Each of electrode is at least partly exposed.Control unit be configured such that can portable module extremely Controllably switch between few two kinds of operation modes：

First mode, wherein monitoring unit and monitoring and bifunctional electrodes function association；With

Second mode, wherein stimulating unit and stimulation and bifunctional electrodes function association.

Module is configured as contributing between the target body portion and bifunctional electrodes of object and opposite body Skin contact partly is established simultaneously between monitoring electrode (relative to target body portion), to allow, in the first mode, The cardiac parameters of object are obtained by monitoring the electrical activity at difunctional and monitoring electrode.

Module is further configured to contribute between the two in target body portion and bifunctional electrodes and stimulating electrode Skin contact is established, to allow, in a second mode, by inducing electric signal electric nerve between stimulating electrode difunctional At least one of stimulation target body part peripheral nerve.

In some embodiments, one or more cardiac parameters include heart rate and/or heart rate variability (HRV).

In some embodiments, monitoring unit is configured for the electrocardiography (ECG) of object.

In some embodiments, module is configured as independently being kept for target body portion.

In some embodiments, target body portion is the interior section of wrist, arm, neck, leg and/or forearm.

In some embodiments, at least one peripheral nerve is the median nerve in wrist.

In some embodiments, stimulating electrode is the first stimulating electrode and stimulus signal is the first stimulus signal, and Module further comprises being mounted in bottom surface/on the second stimulating electrode, for example be at least partly exposed and so as to double Functional electrode positions between the first stimulating electrode and the second stimulating electrode.

Module is further configured to contribute to establish skin contact between target body portion and the second stimulating electrode, To allow, in a second mode, the second stimulus signal is induced between bifunctional electrodes and the second stimulating electrode, optionally Either simultaneously or alternately with the first stimulus signal, at least one of electrical nerve stimulation target body portion peripheral nerve.

In some embodiments, stimulating electrode is the first stimulating electrode and stimulus signal is the first stimulus signal, and Module further comprises being mounted in bottom surface/on the second stimulating electrode and third stimulating electrode, such as by least partly Exposure, and wherein the first stimulating electrode, bifunctional electrodes, third stimulating electrode and the second stimulating electrode are substantially distinguished line Arrange to property.

Module is further configured to contribute to establish skin between target body portion and second and third stimulating electrode Skin contacts, and to allow, in a second mode, the second stimulation letter is induced between third stimulating electrode and the second stimulating electrode Number, optionally either simultaneously or alternately with the first stimulus signal, to the second periphery god in electrical nerve stimulation target body portion Through.

In some embodiments, wherein target body portion is the interior section of wrist and at least one peripheral nerve is Median nerve in wrist, the second peripheral nerve are the ulnar nerves in wrist.

In some embodiments, stimulus signal is joined by the stimulation determined based on the cardiac parameters obtained in the first mode Number characterization.

In some embodiments, stimulation parameter is selected from：The frequency of voltage signal and/or current signal, intensity, amplitude, Duration, waveform, intermittence and polarity.In some embodiments, module is modular, such as to allow removably It is attached to wearable device.In some embodiments, wearable device is the intelligence band or smartwatch for including processing circuit, And module and wearable device are function associations.In some embodiments, module is further configured to via can wear The user interface for wearing device is controllable.In some embodiments, electrode quilt on the outer surface of wearable element is monitored Expose at least partly, and wherein difunctional and stimulating electrode on the inner surface of wearable element by sudden and violent at least partly Dew.

According to the aspect of some embodiments, wearable device is provided comprising module as described above and configuration For the band worn around the limbs of object.Band has the inner surface and the outer surface.Electrode is monitored on the outer surface by least partly Exposed and difunctional and stimulating electrode is at least partly exposed on an internal surface.Target body portion positions in limbs.

In some embodiments, band further comprises user interface, is configured to contribute to the operation of control module. In some embodiments, user interface includes display, is configured to provide for the relevant figure instruction of operation with module.One In a little embodiments, figure instruction includes the cardiac parameters obtained in the first mode and/or the thorn obtained in a second mode Swash parameter.In some embodiments, user interface is configured as showing that the ECG/HR/HRV of object is read during second mode Number.In some embodiments, wearable device further comprises the battery for providing electric power to maintain it to operate.At some In embodiment, band further comprises communication unit, is configured to contribute to and the such as intelligent hand of external module or computing element The data of the communications such as machine, computer, Cloud Server and/or control.

According to the aspect of some embodiments, the method for operating wearable device as previously disclosed is provided, Including following step：

Wrist around object fastens wearable element, so as to the inside portion of stimulating electrode and bifunctional electrodes and wrist Divide skin contact, wherein median nerve and/or ulnar nerve positioning of the bifunctional electrodes in wrist；

It selects first operator scheme and opposite body part is made to be contacted with monitoring electrode.

By monitoring electrical activity, the heart-related activity of measurement object between monitoring electrode and bifunctional electrodes；

The data of research and application and cardiac parameters are determined by it through the processing unit；

Stimulation parameter is determined based on cardiac parameters；

Second operator scheme is selected, and by generating stimulus signal between stimulating electrode and bifunctional electrodes, in hand Apply electro photoluminescence at the interior section of wrist.

In some embodiments, method further comprises, the selection second operator scheme the step of and then answers The step of with the selection first operator scheme, measures heart-related activity, and determines stimulation parameter, newer to obtain Cardiac parameters, and therefore adjust stimulation parameter.

The certain embodiments of the present invention may include in advantage above some, it is all or do not include above excellent Point.According to drawings included herein, described and claimed, further advantage can be aobvious and easy to those skilled in the art See.The aspect and embodiment of the present invention are further described in following discussion book and the appended claims.

Methods herein and/or the embodiment of device can include that artificially, automatically or combinations thereof ground carries out or complete At the task of selection.Implement some embodiments by means of the component including hardware, software, firmware or combinations thereof.In some realities It applies in mode, some components are general purpose module, such as all-purpose computer or processor.In some embodiments, some components It is special or customizable component, such as circuit, integrated circuit or software.

For example, in some embodiments, some in embodiment may be implemented as by data processor --- example Such as, it is general or customized computer a part --- multiple software instructions of execution.In some embodiments, at data Reason device or computer may include for storing instruction and/or the volatile memory of data and/or for storing instruction and/or The nonvolatile memory of data, for example, magnetic hard-disk and/or removable media.In some embodiments, implement to include net Network connects.In some embodiments, implement include user interface, generally include input unit (for example, allow order with/ Or the input of parameter) and output device (for example, allow reporting operations parameter and result) in it is one or more.

Description of the drawings

Some embodiments of present disclosure are described herein with reference to attached drawing.Description makes some embodiment party together with attached drawing It is apparent to those of ordinary skill in the art how formula can be put into practice.Attached drawing is the purpose for illustrative description and is not intended to The CONSTRUCTED SPECIFICATION of embodiment is shown with basic comprehension more details required in this invention.For the sake of clarity, describe in attached drawing Some object nots to scale (NTS).

In the accompanying drawings：

Fig. 1 a schematically depict the side view of the module embodiment of present disclosure according to some embodiments；

Fig. 1 b schematically depict the vertical view of the module of Fig. 1 a according to some embodiments；

Fig. 1 c schematically depict the upward view of the module of Fig. 1 a according to some embodiments；

The method that Fig. 2 schematically depicts the module of operation diagram 1a-1c according to some embodiments；

Fig. 3 schematically depicts the internal circuit of the module embodiment of present disclosure according to some embodiments；

Fig. 4 a schematically depict the wearable cell embodiment of present disclosure according to some embodiments, match It is set to the weared on wrist around user；

Fig. 4 b schematically depict the wearable member of Fig. 4 a of the weared on wrist around user according to some embodiments Part；

Fig. 4 c schematically depict the wearable member of Fig. 4 a of the weared on wrist around user according to some embodiments Part；

It is single that Fig. 5 a-5b depict the monitoring before and after second generation model of the wearable element using Fig. 4 a is treated The result of cardiac parameters on object；

Fig. 5 c-5e depict the monitoring using one group of 22 object of second generation model pair of the wearable element of Fig. 4 a and control The result for the treatment of；

Fig. 5 f-5g are depicted before and after the treatment of the second generation model of the wearable element using Fig. 4 a to single The result of the ECG records of object；

Fig. 6 schematically depicts the monitoring of one group of 52 object of second generation model pair using the wearable element of Fig. 4 a With the result for the treatment of；

Fig. 7 a schematically depict the wearable cell embodiment of present disclosure according to some embodiments, match It is set to the weared on wrist around user；

Fig. 7 b schematically depict the wearable member of Fig. 7 a of the weared on wrist around user according to some embodiments Part；

Fig. 8 a schematically depict the wearable cell embodiment of present disclosure according to some embodiments, match It is set to the weared on wrist around user；

Fig. 8 b schematically depict the wearable member of Fig. 8 a of the weared on wrist around user according to some embodiments Part；

Fig. 9 a schematically depict the forward sight of the smartwatch embodiment of present disclosure according to some embodiments Figure；

Fig. 9 b schematically depict the rearview of the smartwatch of Fig. 9 a according to some embodiments；

Figure 10 schematically depicts the block diagram of monitoring and therapy devices according to some embodiments；With

Figure 11 schematically depicts the method treated and monitored for recurrence according to some embodiments.

Specific implementation mode

Unless specified otherwise herein, all technical and scientific terms used herein has and fields ordinary skill of the present invention The identical meanings that personnel are commonly understood by.In the case of a conflict, it is subject to the patent specification including definition.As used herein , indefinite article "one" and "an" mean "at least one" or " one or more ", unless context is expressly otherwise Regulation.

With reference to description and attached drawing, it is better understood with the principle, purposes and implementation of teaching herein.It is presented herein poring over Description and attached drawing after, those skilled in the art can implement teaching herein without excessive effort or experiment. In attached drawing, identical reference numeral can refer to identical part from beginning to end.

As used herein, " treatment " also refers to one or more physiological conditions, state, property, characteristic, function And/or movable change, change, realization, adjusting and/or processing action." cardiac function " and " cardiomotility " interchangeably makes With." heart function parameter/cardiomotility parameter/cardiac parameters " also refers to for evaluating/estimation/and quantifies heart rate and heart rate The parameter of variability and/or acquisition/measurement ECG, as will be detailed later.

As used herein, " electric nerve adjusting " and term " nerve modulation " and " nerve-stimulation " can be interchangeable And with also referring to electric ground/electromagnetically/electromechanical ground, Non-Invasive/non-invasively nerve modulation neuromechanism or nerve, That is, low-level electrical nerve stimulation.

As used herein, two or more elements (such as two electrodes, electrode and processing circuit, measuring device and Processor etc.) between term " association " also refer to physical connection between element etc., function association, electricity association, machinery Association, and/or electromechanical association, and/or its arbitrary combination.

As used herein, term " wearable element " and " wearable device " can be interchangeably used.

As employed herein, term " user ", " object " and " patient " can be interchangeably used.

The first embodiment of present disclosure is schematically depicted in Fig. 1 a-1c, as described herein.Fig. 1 a according to Some embodiments schematically depict the side view of module 100.Module 100 includes module body 110.Module body 110 includes Two opposite surfaces：Inner surface 114 (bottom surface) and outer surface 118 (top surface).Stimulating electrode 122 and bifunctional electrodes 126 be installed on inner surface 114 in module body 110/on, the outer surface 142 so as to stimulating electrode 122 and difunctional electricity Both outer surfaces 146 of pole 126 are exposed.Monitoring electrode 132 be installed on outer surface 118 in module body 110/ On, the outer surface 152 to monitor electrode 132 is exposed.In some embodiments, stimulating electrode 122 and difunctional electricity Pole 126 is protruded from inner surface 114, and/or monitoring electrode 132 is protruded from outer surface 118.

Fig. 1 b and Fig. 1 c schematically depict the top and bottom perspective views of module 100 according to some embodiments, point Outer surface 118 and inner surface 114 are not shown.

Module 100 is configured as allowing switching between the two operating modes.At first operator scheme (" monitoring pattern ") In, monitoring electrode 132 is associated with 126 electricity of bifunctional electrodes.In second operator scheme (" stimulus modality "), stimulating electrode 122 It is associated with 126 electricity of bifunctional electrodes and opposite polarity can be respectively provided with.

In some embodiments, module 100 is configured as being kept or being placed for the target body portion of user On the target body portion of user, so as to both stimulating electrode 122 and bifunctional electrodes 126 with target body portion skin Contact, and so that user can simultaneously be generated and monitoring electricity by so that monitoring electrode 132 is contacted with opposite body part The skin contact of pole 132.

As used herein, " skin contact " between conductive object and body part also refers on body part Being in direct contact between skin and conductive object and the skin on body part and the mediate contact (example between conductive object Such as, via gel layer, the saline solution etc. between object and body part, or carry or impregnate the medium of such liquid), Allow that conductive object is made to be associated with body part electricity.

When respectively on the left side of user's heart and when the right of user's heart positions, such as by respectively from the first body Part and the second body part obtain electric signal (for example, by monitoring left finesse (the first body part) and right index finger (the second body Body portion) between potential difference) to allow to carry out ECG on user, two body parts (such as right arm and left leg, Yi Duiqian Arm, the right hand refer to be referred to or the right hand refers to left forearm etc. with left hand), or " the first body part " and " the second body part " it may be said that It is " opposite "." two unique body parts " also refers to " target body portion ", and (it can be with " the first body Point " be interchangeably used) and " opposite body part " (it can be interchangeably used with " the second body part ").

In the first mode of operation, can by make bifunctional electrodes 126 and monitoring electrode 132 respectively with the first body Divide and carry out the ECG on user with the second body part skin contact, and for example, monitoring bifunctional electrodes 126 and monitoring are electric The time change of potential difference between pole 132, for example, using potentiometer/potentiometer associated with it, as described in detail below.

In this second mode of operation, stimulating electrode 122 and bifunctional electrodes 126 be connected to two of power supply it is opposite (polarity) terminal.By establishing potential difference between stimulating electrode 122 and bifunctional electrodes 126, intended body can be passed through Part, particularly, by target nerve or the induced current around target nerve, as described in detail below.

In some embodiments, module body 110 is flexible.In some embodiments, in outer surface 118 is parallel to Surface 114.In some embodiments, module body 110 is bending or spill.In some embodiments, electrode is monitored 132 with 126 phase antidirection finding of bifunctional electrodes.In some embodiments, each of electrode has different diameters.At some In embodiment, module body 110 is made of plastics or other materials based on polymer.In some embodiments, electrode by Noncorroding metal such as stainless steel alloy is made.In some embodiments, electrode can be coated with non-sticky and conductive coating.

In some embodiments, module 100 is wearable, or be configured to wearable device/element machinery association/ It is placed in wearable device/element.Module (in wherein module is wearable embodiment) or wearable device can be with It is shaped, for example, being bracelet, band, cuff, ring, waistband, neck ring or chain.In some embodiments, module can be embedded into shirt And/or in trousers in (for example, in sleeve of shirt) or gloves or socks.In some embodiments, can use adaptation, can Patch, paster or the adhesive tape of removal independently keep module, so as to stimulating electrode 122 and bifunctional electrodes 126 and the first body Partial skin contacts, and outer surface 152 keeps exposure and the second body part is accessible (reachable).

As used herein, when --- being placed for body part at it or after be attached to body part --- object Body is held in place in no any action on the part of user, and object can be referred to as body part being " solely It on the spot keeps ".Thus, for example, when preventing from sliding wrist due to being fastened around it, it may be said that independently around wrist Keep wrist-watch.In contrast, the wrist-watch (and not being fastened around wrist) kept in the hand is not kept independently.Such as this What text used, term " keeping (held) " and " independently keeping " based on context can be interchangeable.

In some embodiments, module 100 is configured as contributing to applying treatment to (and independently being protected for it Hold) different body part (and being monitored on it), specifically, body part of different shapes.Some in this way Embodiment in, module 100 is flexible, flexibility allow electrode 122 with 126 and body part of different shapes (compare Such as arm and the back of the body) between establish skin contact.

Fig. 2 presents the method 200 of operation module 100 according to some embodiments.In step 210, by making interior table Face 114 leans on target body portion, makes stimulating electrode 122 and bifunctional electrodes 126 and target body portion (the first body Point) skin contact.

In a step 220, first operator scheme is selected.

In step 230, user is by the inside portion of opposite body part (the second body part), such as finger or forearm (opposite with target body portion) is divided to be placed on monitoring electrode 132.It measures between monitoring electrode 132 and bifunctional electrodes 126 Potential difference, to user carry out ECG.When completing ECG, (it in some embodiments can be by including in module 100 User interface or external smart body associated with it (agent) --- user interface graphical on external device (ED) and/or can Insight is listened to indicate) when, user moves opposite body part and leaves monitoring electrode 132.By the time change of the measurement of potential difference The value of heart function parameter (referred to as " cardiac parameters ") such as heart rate and HRV of monitoring is obtained, as described in detail below.

In step 240, the acquisition value determination of cardiac parameters based on monitoring is applied to follow-up at target body portion The parameters of electrical stimulation (referred to as " stimulation parameter ") of nerve modulation, such as the current strength of alternating current, duration and/or frequency, As described in detail below.

In step 250, second operator scheme is selected.

In step 260, by stimulating electrode 122 and bifunctional electrodes 126 (it is respectively provided with opposite polarity) it Between apply electrical stimulation signal (referred to as " stimulus signal "), realize at least one of target body portion nerve (such as in left finesse Median nerve) nerve modulation.More specifically, via pathway --- it includes stimulating electrode 122, bifunctional electrodes 126 and close to or section including (may be partly) at least one nerve region --- conduct electric current.Acquiescently, stimulation letter It number is characterized by the stimulation parameter that determines in step 240, but user can determine artificially to change stimulation parameter or selection not Same stimulation parameter.

Term " stimulus signal " about electric nerve-stimulation refer to electrode to (it is attached to target body portion, than Such as at least one of electric nerve-stimulation target body part nerve) between the voltage/current signals that apply.About stimulation The term " stimulation parameter " of signal refers to the parameter of characterization stimulus signal comprising duration of stimulus signal, amplitude, most Big intensity, frequency and waveform and waveform and inter-pulse time interval --- when stimulus signal includes a series of pulses.Note Meaning, one or more time dependence functions are also contemplated by using term " stimulation parameter " with broad sense.For example, sinusoidal wave function can To characterize by its amplitude, frequency and mutually, but term " stimulation parameter " will also be used to cover the function with more complicated waveform, And discrete function.

In some embodiments, step 260 can include to apply intermittent stimulus signal (i.e. voltage/current signals), That is, a series of electric pulses (each electric pulse is generally Brief Duration stimulus signal).In some embodiments In, can be controllably --- automatically or manually --- change the time interval between gradually electric pulse (" boost pulse ") With the shape (modulating, waveform) of each pulse.In some embodiments, boost pulse can be two-phase, that is to say, that The substantially and then negative electricity laminate section of pulse after the positive electricity laminate section of pulse.In some embodiments, (referred to by positive voltage Showing conductive charge) area of part covering is substantially equal to area cover by negative part, and it is sufficiently narrow to work as pulse width Prevent/minimize when (being, for example, less than 1msec) electrolysis generation (its may by electric current by the body tissue comprising fluid (in mesh Mark body part in) flowing cause).

In some embodiments, step 260 includes additionally or alternatively to apply continued stimulus signal.

In some embodiments it may be desirable to as little as 15 seconds to measure heart rate, need as little as 30 seconds with measure ECG reading, and And need as little as 60 seconds to measure HRV.In some embodiments, nerve modulation in as little as 1 minute can be to influencing heart work( It can or realize that health status is enough.Stimulate the period (that is, using module, such as 100 application process of module, such as Method 200), including both monitoring and nerve modulation, about 6-7 minutes may be spent.It can also apply longer or shorter lasting The monitoring and treatment (for example, period can be second, minute, day, week, the moon or year for continuously monitoring and treating) of time.

As used herein, " heart rate " is defined as heartbeat number/unit interval, such as passes through ECG histograms or pulse The number at the peaks RR measures in reading." intervals RR " (RR) is the interval between the gradually peak of ECG signal." heart rate variability " (HRV) variation phenomenon of the time interval between normal cardiac activity (non-arrhythmia cordis heartbeat) is referred to gradually, and can be with It is quantified by SDNN, rMSSD or pNN50 defined below.

In some embodiments, the ECG or heart rate measurement that following data collection can be in step 230：HRV、RR、 AVNN, SDNN, rMSSD, pNN50, LF and HF.Time domain HRV analyzes parameter：" intervals NN " (" normally to normal interval ") quilt The time interval (msec) being defined as between gradually normal beats." average NN " (AVNN) is defined as being averaged for one group of interval NN Value." standard deviation of NN " (SDNN ms) is defined as the standard deviation at one group of interval NN, and represents autonomic nerves system Parasympathetic nerve (calmness) activity." root mean square of successive difference " (rMSSD msec) is defined as adjacent in one group of interval NN (gradually) between the intervals NN difference square average value square root, and also represent the parasympathetic nerve of autonomic nerves system (calmness) activity." NN50 " is defined as differing by more than the number at the intervals pair gradually NN of 50msec in one group of interval NN.“NN50 Percentage and/or ratio " (pNN50) be defined as in NN50 divided by group the gradually total number at the intervals NN.Frequency domain HRV parameter packets It includes：" low-Frequency Active " (LF ms²) be defined as ECG reading in or in the reading of any other heart rate monitoring system it is low- The general power of frequency Fourier coefficient --- i.e. 0.04-0.15Hz ---, and represent the parasympathetic nerve of autonomic nerves system Activity, described any other heart rate monitoring system such as heart rate tracker etc. comprising based on electric measurement, optical measurement, pressure Power measurement or the measurement of any other type and the monitoring system of method, wherein general power are defined as all Fouriers in range The summation of the squared absolute value of coefficient." height-Frequency Active " (HF ms) is defined as height-frequency of the reading of heart rate monitoring system The general power of rate fourier coefficient --- i.e. 0.15-0.4Hz --- and the sympathetic nerve (excitement for representing autonomic nerves system (speeding up)) activity.LF and HF can also be calculated and be presented with n.u., and the ratio (LF/HF ratios) of LF and HF are by being Count the important measured value calculated because it express balance between sympathetic nerve and parasympathetic and they to heart rate With the direct effect of cardiac rhythm.Other frequency domain parameters such as TP (ms can also be calculated²) and VLF (ms²)。

In some embodiments, module 100 can be used for implement monitoring without implement nerve modulation and otherwise also So.For example, the value (obtaining in step 230) of cardiac parameters based on monitoring, user can determine to skip over nerve modulation or base In the value of the cardiac parameters of monitoring, can determine not needing nerve modulation in step 240.

In some embodiments, user can artificially select stimulation parameter, skip over step 210 to 240.For example, with Family can select the stimulation parameter of the preceding period preserved.In some embodiments, user can set from a large amount of acquiescence stimulations Surely stimulus settings are selected, skip over step 210 to 240.Giving tacit consent to each of stimulus settings can be based on different groups of stimulation parameter.

In some embodiments, module 100 is configured as (such as passing through by radio communication or by wire communication USB cable) it sends information to external smart body (external device (ED)) and receives information from external smart body (external device (ED)), it is described outer Smart mobile phone, smartwatch, home network center (the home hub) of portion's intelligent body (external device (ED)) such as user.Measure number According to, such as the variation of measurement of potential difference between bifunctional electrodes 126 and monitoring electrode 132 is sent to external smart body, For example smart mobile phone, computer, Cloud Server etc., wherein measurement data are handled to obtain the heart of monitoring in step 230 The value of parameter.Also using the acquisition value of the cardiac parameters of monitoring, step 240 moderate stimulation parameter is carried out really by external smart body It is fixed.The acquisition value (referred to as " data of acquisition ") and stimulation parameter of the cardiac parameters of monitoring can be stored on external smart body Memory in for further reference to as described below.Independently of the data of acquisition, stimulation parameter can also be by external smart Body is conveyed directly to module 100, such as the parameter preset of some stimulation protocol/agreement to obtain desired physiological role.

In some embodiments, method 200 may be embodied in switching/alternating between stimulus modality and monitoring pattern. After (default) period of stimulation, module, which can automatically switch, returns to monitoring pattern to obtain the update of the cardiac parameters of monitoring Value.Therefore stimulation parameter is conditioned and (considers updated value).Then module can switch returns to stimulus modality and restores to apply Stimulation, and so on.

It in some embodiments, can be in response to specific physiological status according to the number obtained by external monitoring devices According to adjusting stimulation parameter.According to from module or additionally/optionally obtaining from external monitoring devices during monitoring pattern The information taken, module can provide automatic stimulation feedback response.For example, module can be reprogrammed with when the HRV readings obtained Being applied when low (being less than the normal value such as indicated by above mentioned cardiology guide) has low frequency --- 0.1- 5.0Hz --- current signal, and when HRV reading it is high when apply with high-frequency --- such as 5-200Hz --- electro photoluminescence Electric current, or vice versa, to respectively increase and reduce HRV, and thus provide automatic feedback answer method, to be based on The updated value of the heart function parameter of monitoring optimizes stimulation parameter.Other stimulation parameters and the heart of monitoring can also be used to join Number.

In some such embodiments, method 200 includes round-the-clock monitoring and treatment, and module 100 is configured For operation mode as permission.Monitoring can be continuous or planned, for example, the minute or small of each predetermined number When, as suggested by healthcare provider.In some embodiments, the data of the acquisition from monitoring pattern can be recorded With the value of parameters of electrical stimulation --- it uses, and can for example be deposited in the memory of external device (ED) in each stimulation period The pattern and sequence of the individual parameters of electrical stimulation of storage successful (successful), further to treat, such external device (ED) Can be smart mobile phone, smartwatch, computer, Cloud Server etc..In some embodiments, external device (ED) includes ergonomics Habit ability allows module such as module 100 to identify the successfully stimulation period, thus needs to customize and optimize for personal entity Treatment, in some embodiments, artificial learning ability is based on the data for storing and analyzing on Cloud Server.

In some embodiments, module 100 is configured as measuring the additives amount beyond the potential difference between electrode, than The electric current that such as passes through between the electrodes, magnetism, impedance change.In some embodiments, in step 230, it can measure Additives amount beyond the potential difference between electrode, and the measurement data determination for also considering additives amount is true in step 240 Fixed stimulation parameter.Optionally relative to ECG, module 100 can contribute to by measuring the pulse by blood flow in artery The impedance variations that wave causes obtain heart rate.

In some embodiments, module 100 further comprises one or more other cardiac function monitoring assemblies, It is configured to monitor cardiac function by implementing such as optical measurement or blood pressure measurement.It is one or more other by also considering The measurement data of cardiac function monitoring assembly can obtain the heart work(monitored using bifunctional electrodes 126 and monitoring electrode 132 The value of at least one of energy, so as to allow improved cardiac parameters determination/estimation.

Advantageously, module or device, which can have, both monitors and handles cardiac function, and enhancing nerve-cardiovascular system System interaction, and can also have following effectiveness：(a) as health auxiliary, this is because above mentioned cardiomotility Correlation between health status, and (b) body-building is used as to assist, allow user before the physical training period, period Influence its cardiomotility and HRV later, for example, with improve athletic performance and restore and thus reduce injured possibility and The whole exercise performance of enhancing and target.According to some embodiments, stimulation ginseng can be adjusted based on the measurement data obtained recently Number, in order to provide quick regulating loop, and the history for being also based on the measurement data of acquisition is adjusted, in order to provide length Phase circuit.

Referring now to Figure 3, it schematically depicts the internal circuit of module 300 according to some embodiments.Module 300 Provide the Example embodiments (and include its numbered component (being shown in Fig. 1 a-1c)) of module 100.Module 300 further comprise the cardiac function monitoring of control unit 310, communication unit 320 including potentiometer/potentiometer (not shown) Unit 334 (referred to as " monitoring unit 334 ") includes the electro photoluminescence induction (referred to as " stimulating unit of unit 338 of power supply (not shown) 338 "), first switch 344 and second switch 348.

As used herein, " potentiometer " or " potentiometer " is also referred to for measuring the electricity between at least two positions The device of potential difference, including analog voltage meter such as galvanometer, digital voltage meter, field-effect transistor potentiometer (FET-VM), show Wave device etc..In some embodiments, measuring can be continuous and/or interval.In some embodiments, potential difference can Discretely to be sampled.As used herein, " power supply " also refer to being capable of induced current and/or electricity between the two positions The device of potential difference, including battery, the sources EMF, the source direct current (DC), the source alternating current (AC), via electromagnetic induction generate electric current dress It sets.As used herein, term " switch " also refer to for control module or part thereof one or more functions and/ Or the purpose of parameter contributes to the element that control and/or signal are sent.In some embodiments, switch can contribute to module At least two parts between it is controllable electricity association.

Communication unit 320, monitoring unit 334, stimulating unit 338, first switch 344 and second switch 348 are single with control Member 310 is associated with.Stimulating unit 338 is further associated with stimulating electrode 122 and with second switch 348.Bifunctional electrodes 126 into one Step is associated with first switch 344 and with second switch 348.Monitoring unit 334 further with first switch 344 and with monitoring electrode 132 associations.Associated element is shown through straight solid line connection (unnumbered).Associated framework described herein is exemplary , and other association frameworks can be applied.

In some embodiments, control unit, such as control unit 310, including (the two is equal for processing circuit and memory It does not show).Processing circuit can be application-specific integrated circuit (ASIC), programmable processing circuit such as FPGA, firmware etc..At some In embodiment, memory is non-transitory memory.Memory may include solid-state memory, magnetic memory, photon storage Device etc..In some embodiments, memory is temporary memory.Control unit may further include at least one configuration For the filter of filtered electrical signal, at least one voltage and or current amplifier, at least one modulus electric signal transducer and/ Or at least one digital-to-analogue electric signal transducer (not shown).

First switch 344 is configured as controllably electricity association and separating monitoring unit 334 and bifunctional electrodes 126, and And to controllably association and separating monitoring electrode 132 and bifunctional electrodes 126.Second switch 348 is configured as can control Ground electricity association and separation stimulating unit 338 and bifunctional electrodes 126, and to controllably be associated with and detach stimulating electrode 122 and bifunctional electrodes 126.First switch 344 and second switch 348 are controlled by control unit 310.

In the first mode of operation, bifunctional electrodes 126 are electrically separated with stimulating unit 338 and electric with monitoring unit 334 Association, to help to monitor the measurement of potential difference between electrode 132 and bifunctional electrodes 126.In this second mode of operation, double Functional electrode 126 is electrically separated with monitoring unit 334 and is associated with 338 electricity of stimulating unit, to by 122 He of stimulating electrode Induced current between bifunctional electrodes 126 and contribute at least one of electrical nerve stimulation target body portion nerve, substantially Above as described in the description of Fig. 2 above.

Monitoring unit 334 is configured as the potential difference of transmission/transmission measurement data such as measurement to control unit 310. In some embodiments, control unit 310 be configured as processing measurement data with obtain monitoring cardiac parameters (such as heart rate, HRV) and the value of stimulation parameter, it is used for follow-up/subsequent nerve modulation.In some embodiments, the processing of measurement data is outside It is carried out on portion's intelligent body, as described in the description in module 100, method 200, and be detailed further below.At some In embodiment, monitoring unit 334 is configured as carrying out ECG to the user of module 300.

Stimulating unit 338 is configured as raw between stimulating electrode 122 and bifunctional electrodes 126 in this second mode of operation At electric signal (such as voltage signal or current signal).Stimulating unit 338 is further configured to be ordered from control unit 310 It enables, such as stimulation parameter.Stimulation parameter can specify that the time dependence of the electric signal of generation.

Specifically, in some embodiments, stimulating unit 338 is configured to automatically regulate in stimulating electrode 122 The voltage and frequency applied between bifunctional electrodes 126, such as to obtain desired current amplitude and/or maximum intensity.Such as Used herein, " maximum intensity " of stimulus signal refers to larger between top and the absolute value of its lowest trough.

Stimulating unit 338 may include, for example, AC power supplies or electric signal generator, so as to what is generated by stimulating unit 338 The intensity of voltage/current, frequency and waveform (including characterization voltage/current --- including the pulse of continuity voltage/current, interval Property voltage/current pulse and burst mode --- parameter) can controllably be changed according to stimulation parameter, to realize target The nerve modulation of at least one of body part nerve, as described in the description above with Fig. 2.

Communication unit 320 is configured as sending information to external smart body, and/or receives information, institute from external smart body State external smart body such as smart mobile phone, smartwatch, intelligence band, tablet and/or personal computer.Can wirelessly and/or Pass through sending and receiving for line implementation information (such as stimulation parameter of the cardiac parameters of monitoring, determination).Communication unit 320 can be with It is configured for by means of cellular network and/or Wi-Fi telecommunications (such as to the cloud storage of user, the individual calculus of user Machine, user healthcare provider computer system and/or user doctor/caregiver personal computer).Optionally Or additionally, communication unit 320 can be configured for for example, short by bluetooth, NFC (near-field communication) technologies and/or Wi-Fi Cheng Tongxin (such as smart mobile phone or tablet to user).

Specifically, in some embodiments, communication unit 320 can be used for information from control unit 310 After to user smart mobile phone/smartwatch and order from smart mobile phone/smartwatch of user relayed into control unit 310, to contribute to by smart mobile phone/smartwatch control and operation module 300.

In some such embodiments, 334 measurement data of monitoring unit is handled in step 230 to determine the heart of monitoring Determine that stimulation parameter can be implemented on the smart mobile phone of external intelligent body such as user in the value and step 240 of dirty parameter. In some such embodiments, control unit 310 does not include processor, to reduce the number of component in control unit 310 With the size of control unit 310, and therefore reduce module 300 size.

The another embodiment of present disclosure is schematically depicted in Fig. 4 a-4c.Fig. 4 a-4c are implemented according to some Mode schematically depicts wearable element 400 (that is, wearable device).Wearable element 400 provides module 100 Example embodiments and wrist, arm or forearm (and in some embodiments, the neck for being configured as surrounding user Or leg) wear and realize wrist in median nerve nerve modulation.In some embodiments, wearable element 400 is shaped For band or bracelet.

As shown in Fig. 4 a, wearable element 400 includes (unnumbered) extension of inner periphery along wearable element 400 Inner surface 414, and (unnumbered) extension of excircle along wearable element 400 outer surface 418.Wearable element 400 Fastener/buckle (not shown) is may further include, helps to surround wrist and tightens and loosen wearable element 400, at it It is upper to place wearable element 400, and remove wearable element 400 from it.Wearable element 400 is shaped as the one of band wherein In a little embodiments, band can be elastic.In some such embodiments, wearable element 400 does not include fastener.

Monitoring electrode --- monitoring cathode 420 --- is embedded into outer surface 418/on, to monitor the outside of cathode 420 Surface is exposed.Bifunctional electrodes --- difunctional anode 424 --- are embedded into inner surface 414/on, so as to difunctional anode 424 outer surface is exposed, and with monitoring 420 phase antidirection finding of cathode.Stimulating electrode --- stimulation cathode 432 --- is embedding Enter in inner surface 414/on, to stimulate the outer surface of cathode 432 to be exposed.In some embodiments, difunctional anode 424 protrude with stimulation cathode 432 from inner surface 414, and/or monitoring cathode 420 is protruded from outer surface 418.

Wearable element 400 further comprises stimulating unit 440 (i.e. electro photoluminescence induction unit), monitoring unit 450, timing The display 460 of device 454 including graphic user interface such as touch screen, communication unit 474 and battery 480.

In some embodiments, wearable element 400 further comprises 464 (example of one or more adjusters (knob) Such as button).In some embodiments, display 460 include touch screen, and adjuster 464 be used to control it is wearable Element 400 operates.In some embodiments, wearable element 400 further comprises the charger for charging to battery 480 Socket 494.In some embodiments, battery 480 can be by wireless charging, and can also be removable.

Paying attention to the positioning for the component (such as monitoring unit 450, timer 454) numbered above in wearable element 400 is It illustratively, and can be using other positioning of 400 inner assembly of wearable element.

Fig. 4 b are schematically depicted from side perspective view around the wearable of the fastening of wrist 484 according to some embodiments Element 400, wherein wrist interior section 486 are visual (that is, interior sections of wrist 484).It further illustrates Hand 482 (adjacent wrist 484), is visual so as to the palm (unnumbered) of hand 482.Median nerve 488 extends along wrist 484 Far from hand 482.

Fig. 4 c present the enlarged view of a part of Fig. 4 b comprising wrist 484 and wearable element 400.It does not show Monitor cathode 420.Only it is that the difunctional anode 424 of exposure and stimulation cathode 432 work as the wearable element of wearing on inner surface 414 Not visible when 400, and therefore describe by a dotted line open circles (with describe visual electrode in Fig. 1 a-1c and figure The pattern filling circle used in 4b is opposite) schematically describe each.It is enough that wearable element 400 can surround wrist 484 Tightly fasten, so as to both difunctional anode 424 and stimulation cathode 432 with 486 skin contact of wrist interior section, wherein double Median nerve 488 of the function positive 424 in wrist 484 positions.Compared with difunctional anode 424, stimulation cathode 432 can be with Thumb 498 closer to hand 482 positions.

The wearable element of operation described in basically as in Figure 2 400.In monitoring pattern, user, for example, by opposite Finger (such as the right hand refers to, when wearable element 400 is worn around left finesse, as described in Fig. 4 b) is placed on monitoring cathode On 420, and the time fluctuation for monitoring voltage between cathode 420 and difunctional anode 424 is monitored, to realize that heart rate is surveyed Amount, as being described in detail in following and Fig. 2 description.

Monitoring unit 450 and stimulating unit 440, and timer 454, and adjuster 464, and communication unit 474, with battery 480, and/or with other component liaisons.In monitoring pattern (i.e. first mode), monitoring unit 450 with monitoring cathode 420 and pair The electricity association of both function positives 424, it is electrically separated with stimulation cathode 432.Monitoring unit 450 includes potentiometer (not shown), and And it is configured as monitoring (continuously measure or intermittently measure) monitoring cathode 420 and difunctional anode 424 in monitoring pattern Between potential difference (such as in step 230) make it possible to estimate (projection)/meter to realize heart rate measurement Cardiac parameters (and/or obtaining ECG/HRV readings) are calculated, as being described in detail in the description of Fig. 2.

The value of the cardiac parameters of monitoring can be saved, marked with date, record and cataloguing, to contribute in different time With in different condition --- such as during the break, after the treatment provided after physical exercise and in this second mode of operation --- Comparison between the cardiac parameters of acquisition.In some embodiments, pass through the external intelligence with 400 communication association of wearable element Energy body estimate/calculate.In some embodiments, wherein monitoring unit 450 further comprises computing unit, the calculating Unit includes processor and memory (not showing), by computing unit can estimate/calculate.

Stimulating unit 440 and monitoring unit 450, and timer 454, and adjuster 464, and communication unit 474, with battery 480, and/or with other component liaisons.In stimulus modality (i.e. second mode), stimulating unit 440 with stimulation cathode 432 and pair The electricity association of both function positives 424, it is electrically separated with monitoring cathode 420.(difunctional anode 424 and stimulation cathode 432 are configured To have opposite polarity in stimulus modality).Stimulating unit 440 includes electric signal generator, may include power supply, such as AC or DC power supply, or energized by battery 480.Stimulating unit 440 is configured as generating electrical stimulation signal in stimulus modality.It is based on Stimulation parameter (characterization stimulus signal) that the values of the cardiac parameters of monitoring determines (such as in step 240) can be by stimulating unit 440 using to realize the nerve modulation of median nerve 488.By conducting current through pathway --- it includes difunctional sun Pole 424, stimulating electrode 432 and close to or section including (may be partly) median nerve 488 region --- realize neural It adjusts.Notice that the electric current of pathway and induction is substantially constrained to the interior section of wrist 484, for this meaning, Electric nerve-the stimulation provided in second operator scheme is local.This local electrical stimulation of median nerve 488 can influence nerve Hormonal balance and autonomic nerves system control, and therefore cause secretion and the pressure correlation hormone of nerve stimulation associated hormone The reduction of secretion, to influence heart rate, cardiac rhythm, HRV and/or mood.The controllable electro photoluminescence of median nerve 488 can be because And allow using non-invasive electrodes (i.e. difunctional anode 424 and stimulation cathode 432) indirectly, controllably influence heart rate and HRV。

In some embodiments, communication unit 474 is closed with stimulating unit 440, monitoring unit 450 and/or timer 454 Connection.Similar to communication unit 320, in some embodiments, communication unit 474 is configured as conveying information to one or more External smart body, and receive information from one or more external smart bodies.External smart body can be used to carry out data processing In some or all of and/or wearable element 400 of control, generally as above and in the description of method 200 and module 300 It is described.

In some embodiments, timer 454 can be configured as offer temporal information, can be used for and as follows Relevant operation：Duration of the duration or boost pulse of stimulation and/or monitoring period of time and gradually between boost pulse Time interval duration etc..

Display 460 is configured as the cardiac parameters that display obtains in the first mode of operation.In some embodiments, Adjuster 464 is configured as helping to select one or more heart function parameters to be shown, or is obtained in different measurements One or more of same cardiac functional parameter group, to contribute to the comparison of different time and condition cardiac function. Display 460 can be additionally configured to show heart function parameter during first operator scheme.For example, display 460 can be with Show the real-time or near real-time ECG readings of user's heart.

In some embodiments, without example in fig.4, wearable element 400 does not include display 460 or any The display of type.The value of the cardiac parameters of monitoring can be displayed on the smart mobile phone and/or other external device (ED)s ratio of user On such as smartwatch, tablet, information can be received from wearable element 400 and (such as pass through Wi-Fi, NFC and/or indigo plant Tooth).

In some embodiments, wearable element 400 can be such as intelligent via external smart body (one or more) Mobile phone and/or smartwatch are partially or even wholly controlled and (such as are switched on and off so that start or stop monitoring).One In a little embodiments, wearable element 400 does not include the user interface of adjuster 464 or any other type, and only can be with It is controlled via external smart body (one or more).

In some embodiments, wearable element 400 is configured as surrounding the left finesse wearing of user.In some implementations In mode, wearable element 400 can be worn around both the left finesse of user and right finesse (and can be used for electro photoluminescence Respective nerve therein).

It is single that Fig. 5 a-5b depict the monitoring before and after treatment of the second generation model of the wearable element using Fig. 4 a The result of cardiac parameters on a object.Before stimulation therapy, as shown in Fig. 5 a, SSDN parameters are 37.69, rMSSD ginsengs Number is 26.46, and heart rate is 73bpm.After stimulating the period, as shown in Fig. 5 b, SSDN parameters are 71.58, rMSSD ginsengs Number is 48.93, and heart rate is 63bpm, this indicates significantly improving for both HRV relevant parameters and heart rate.

Fig. 5 c-5e depict the monitoring using one group of 22 object of second generation model pair of the wearable element of Fig. 4 a and control The result for the treatment of.Fig. 5 c show the SSDN parameters of 22 participants, before and after stimulating the period on average significantly It improves.Fig. 5 d show the rMSDD parameters of 22 participants, significantly change on average before and after stimulating the period Into.Fig. 5 d show the heart rate of 22 participants, are significantly improved on average before and after stimulating the period.

The general introduction for the data described in Fig. 5 c-5e is presented in following table：

Fig. 5 f-5g are depicted before and after the treatment of the second generation model of the wearable element using Fig. 4 a to single The result of the ECG records of object.In Fig. 5 f, the arrhythmia cordis of heart can be most clearly noticed, total heart in 5 minutes Beating reaches 326 times, that total VPC in five minutes is 42 (account for total heartbeat 12.8%), and average heart rate is 65bpm. After stimulating the period, as described in Fig. 5 g, arrhythmia cordis is significantly improved, and total heartbeat in 5 minutes is 300 times, and That total VPC in 5 minutes is 8 (account for total heartbeat 2.6%), and wherein average heart rate is 60bpm.

Notice that SDNN, rMSSD, pNN50 and LF/HF are the different parameters that this field is used for analysis of HRV.Low HRV --- such as Low scale by parameter above is quantitative --- it is considered indicating autonomic nerves system to cardiovascular system as mentioned above The communication and control for difference of uniting.The related compounds (correlate) of low HRV may indicate that the cardiovascular health, high-pressure state, difference of difference Sleep or difference physical recovery ability.The result of experiment thus shows HRV significantly improving after the treatment, highlights Disclosed embodiment is used for some potential benefits of situation above.

The effect of having been carried out treatment of the assessment using the second generation model of the wearable element of Fig. 4 a and effect are ground Study carefully, and its result is provided in following table and corresponding Fig. 6.

After Fig. 6 is schematically depicted as a result, which show the average SDNN of group from 34.6 before treatment to treatment 43.6 improvement；With rMSSD from 42.4 improvement after class mean 29.3 to the treatment before treatment.

The part that heart rate is the treating irregular heart pulse strategy in cardiology is reduced, it includes rate controls and rhythm and pace of moving things control System.As a result the heart rate reduction close to 5% is also shown, can indicate neurological susceptibility and the sportsman of the reduction to arrhythmia cordis The heart rate recovery time of middle reduction.

In some embodiments, module or the such as wearable element 400 (and module 100 and 300) of wearable element It is used as body-building device.The HRV data obtained in monitoring pattern can be used to determine before (body) exercise session Improved exercise session plan is established in physical efficiency present situation and help.In addition, being supervised from repetition in prolonging period (such as day, week or moon) Monitoring/evaluation body-building progress can be used for by surveying the HRV data obtained, and can be correspondingly before exercise session, period And/or adjusting to exercise plan is provided later, and/or treatment to application adjusting (use device disclosed herein and The nerve modulation of method application).Moreover, the one side of present disclosure, i.e. nerve modulation ability, it can be by improving HRV Parameter directly enhances physical performance and recovery in exercise session.Trainer can thus by module for before training, During and after monitor and in training improve performance both.

According to some of device disclosed herein and method embodiments, the example exercise session based on monitoring and treatment May include some or all of in the following steps：

Module is placed in wrist and selects monitoring pattern.

HRV is measured, as described above.

Stimulus modality is selected, and determines exercise session target (such as slight, moderate, severe, and/or aerobic or strength With endurance training etc.).It is contemplated that HRV readings determine exercise session target.

When module or the external smart body communicated with module can be according to the data obtained in monitoring pattern and according to taking exercise Section target automatically determines the value of stimulation parameter.For example, processing unit algorithm can be programmed to the acquisition data according to monitoring Parameter and desired period or therapeutic purpose output low frequency rate stimulation (0.5-5Hz) or high-frequency stimulation (such as 100Hz).Also may be used To utilize other monitorings and stimulation parameter.Optionally, trainer can artificially select stimulation parameter.

Module can automatically switch between stimulus modality and monitoring pattern so that the period of monitoring can then pierce Sharp period is read with obtaining newer HRV.Module can read the value for automatically regulating stimulation parameter according to newer HRV.

When section is completed when training, the low frequency stimulation for optimizing body-building recovery can artificially be selected or by mould Block is automatically suggested and is executed.

Optionally, stimulation parameter can computing unit --- it be configured to and other use by Cloud Server or outside Family and/or previous stimulation and the relevant data analysis of measurement determine stimulation parameter --- it provides.

The another embodiment of present disclosure is schematically depicted in Fig. 7a-7c.Fig. 7 a are according to some embodiment party Formula depicts wearable element 700.Wearable element 700 provides the Example embodiments of module 100.Wearable element 700 It is substantially similar to wearable element 400, but difference is to further comprise other stimulation cathode.It is wearable in order to distinguish Electrode electrode corresponding with wearable element 400 in element 700, all electrodes in wearable element 700 are designated new Number, and all other element in wearable element 700 retains its volume of the respective counterpart in wearable element 400 Number.

Wearable element 700 includes monitoring cathode 720, the stimulation stimulation of cathode 732 and second of difunctional anode 724, first Cathode 736.Monitoring cathode 720 be embedded into outer surface 418/on.With monitoring cathode 720 on the contrary, difunctional anode 724 is embedded into In inner surface 414/on.First stimulation cathode 732 and second stimulate cathode 736 be embedded into inner surface 414/on.First stimulation Cathode 732, difunctional anode 724 and second stimulate cathode 736 sequentially to be arranged along the inner periphery of wearable element 700. That is, difunctional anode 724 positions between the first stimulation cathode 732 and second stimulates cathode 736, wherein the first stimulation Cathode 732 is positioned closest to thumb 498.The respective outer surface (unnumbered) of all electrodes is exposed.

In some embodiments, its in the association in wearable element 700 between element and wearable element 400 be respectively Counterpart association it is identical, except additional is related to the second stimulation cathode 736 (it does not have counterpart in wearable element 400) Association other than, it is as described in detail below.

Fig. 7 b schematically depict the wrist with the wearable element 700 worn on it according to some embodiments The view of 484 interior section.Only it is that the difunctional anode 724 of exposure and stimulation cathode 732 are worked as with 736 on inner surface 414 It is not visible when wearing wearable element 700, and the open circles therefore described by a dotted line are schematically described each.Prison Cathode 720 is surveyed not show, it is understood that with difunctional anode 724 on the contrary in outer surface 418/upper positioning (generally class The monitoring cathode 420 being similar in Fig. 4 b).Wearable element 700, which is configured as helping to surround wrist 484, sufficiently tightly to be fastened, So as to difunctional anode 724 and stimulation cathode 732 and 736 simultaneously with 486 skin contact of wrist interior section, wherein difunctional Anode 724 is positioned close to median nerve 488.The first operator scheme of wearable element 700 is substantially similar to wearable element 400 first operator scheme, wherein monitoring cathode 720 and difunctional anode 724 play and monitor cathode 420 and difunctional respectively The similar effect of anode 424.

The second operator scheme of wearable element 700 is similar to the second operator scheme of wearable element 400, but different It is three electrodes, rather than two, it is used for nerve modulation；Electrode is difunctional anode 724 and stimulation cathode 732 and 736. The nerve modulation of median nerve 488 is implemented by being closed at two pathways.(it is similar to and can wear first pathway Wear the pathway being closed in the second operator scheme of element 400) pass through difunctional anode 724, first to stimulate cathode 732 and lean on The first area of first section close or including (may be partly) median nerve 488.Second pathway passes through difunctional sun Pole 724 and second stimulates cathode 736, and the second of the second section close or including (may be partly) median nerve 488 Region.In some embodiments, the first section of median nerve 488 and the second section are identical.

Further operation mode can be applied.For example, stimulating the utilization operation mode of cathode 732 and 736 by change It may include iteration stimulation, compensate wearable element 700 and surround dislocation of the wrist relative to median nerve.

Notice that the presence of the second stimulation cathode (the second stimulation cathode 736) can contribute in stimulus modality through double work( Can anode 724 conduction than maximum current bigger electric current, the maximum current can advantageously/safely pass through difunctional anode 424 conduction, this is because the surface area of the combination of stimulation cathode 732 and 736 is potentially more than the surface area of stimulation cathode 432.

In some embodiments, the first stimulation cathode 732 is also difunctional.In stimulus modality, the first stimulation is cloudy 732 function of pole remains unchanged (that is, 732 function of the first stimulation cathode as described above).However, in monitoring pattern In, the first stimulation cathode 732 is no longer passive and serves as monitoring electrode.More specifically, in monitoring pattern, the first stimulation Cathode 732 is associated with by electricity such as to form substantially equipotential surface, to effectively function as single electricity with difunctional anode 724 Pole.By monitoring in monitoring cathode 720 and the substantially equipotential formed by the first stimulation cathode 732 and difunctional anode 724 The time change of potential difference between surface carries out the monitoring of cardiac parameters.The increased skin provided by the first stimulation cathode 732 Skin contact can potentially allow for obtaining improved ECG readings.

The another embodiment of present disclosure is schematically depicted in Fig. 8 a-8c.Fig. 8 a are according to some embodiment party Formula depicts wearable element 800.Wearable element 800 provides the Example embodiments of module 100.Wearable element 800 It is substantially similar to wearable element 700, but difference is to further comprise other anode, and optionally difference is The spatial arrangement of electrode, as described in detail below.In order to distinguish the electrode in wearable element 800 and phase in wearable element 700 The electrode answered, all electrodes in wearable element 800 are designated new number, and all other member in wearable element 800 Part retains its number of the respective counterpart in wearable element 700.

It is cloudy that wearable element 800 includes monitoring cathode 820, difunctional anode 824, first stimulates cathode 832, second to stimulate Pole 836 and stimulation anode 878.Monitoring cathode 820 be embedded into outer surface 418/on.With monitoring cathode 820 on the contrary, difunctional sun Pole 824 is embedded into inner surface 414/on.First stimulation cathode 832, second stimulates cathode 836 and stimulation anode 878 to be embedded into In inner surface 414/on.First stimulation cathode 832, difunctional anode 824, stimulation anode 878 and second stimulate cathode 836 along The inner periphery of wearable element 800 is sequentially arranged.That is, difunctional anode 824 is in the first stimulation cathode 832 and thorn It is positioned between sharp anode 878, and anode 878 is stimulated to be positioned between difunctional anode 824 and second stimulates cathode 836, In first stimulation cathode 832 closest to thumb 498 position.The respective outer surface (unnumbered) of all electrodes is exposed. In some embodiments, in inner surface/on electrode any one or more of can be bifunctional electrodes.

In some embodiments, its in the association in wearable element 800 between element and wearable element 700 be respectively Counterpart association it is identical, except additional is related to the second stimulation anode 878 (it does not have counterpart in wearable element 700) Association other than, it is as described in detail below.

Fig. 8 b schematically depict the wrist with the wearable element 800 worn on it according to some embodiments The view of 484 interior section.Only be on inner surface 414 exposed anode 824 and 878 and cathode 832 and 836 when wear can It is not visible when wearing element 800, and the open circles therefore described by a dotted line are schematically described each.Monitor cathode 820 do not show, it is understood that with difunctional anode 824 on the contrary in outer surface 418/upper positioning (is substantially similar to figure Monitoring cathode 420 in 4b).Wearable element 800, which is configured as helping to surround wrist 484, sufficiently tightly to be fastened, so as to sun Pole 824 and 878 and cathode 832 and 836 simultaneously with 486 skin contact of wrist interior section, wherein difunctional anode 824 is close Median nerve 488,492 positions and its moderate stimulation anode 878 is positioned close to ulnar nerve 890.The first of the wearable element of third 800 Operation mode is substantially similar to the first operator scheme of wearable element 700, wherein monitoring cathode 820 and difunctional anode 824 play the effect similar with monitoring cathode 720 and difunctional anode 724 respectively.

In some embodiments, in the second operator scheme of wearable element 800, median nerve 488 and ulnar nerve Both 890 by electro photoluminescence simultaneously.The nerve modulation of median nerve 488 can be by being closed the first pathway --- and it passes through double Function positive 824, first stimulates the firstth area of cathode 832 and section close or including (may be partly) median nerve 488 Domain --- it realizes.The nerve modulation of ulnar nerve 890 can be by being closed the second pathway --- its pass through stimulation anode 878, The second area of second stimulation cathode 836 and section close or including (may be partly) ulnar nerve 890 --- it realizes.

Further operation mode can be applied.For example, only one kind in median nerve 488 and ulnar nerve 890 can be by Selectively nerve modulation or median nerve 488 and ulnar nerve 890 can be by alternately nerve modulations.In addition, being pierced by changing Swash the utilization of cathode 832 and 836, operation mode may include iteration stimulation, the dislocation of the wearable element of compensation third 800.

In some embodiments, arrangement of the electrode on inner surface 414 can be different.In some embodiments, double Function positive 824 positions between stimulating cathode 832 and 836, and the second stimulation cathode 836 is in anode 824 and stimulation anode It is positioned between 836, so that the first stimulation cathode 832, difunctional anode 824, second stimulate 878 edge of cathode 836 and stimulation anode The inner periphery for the wearable element of third 800 is sequentially arranged.Such arrangement can be more suitable for have wider wrist and Therefore the user at the interval with larger median nerve 488 and ulnar nerve 890.

In some embodiments, stimulation anode 878 and second stimulates the effect of cathode 836 can be by controllably inverse Turn.That is, wearable element 800 further comprises switching (not shown), user is allowed to match in the first configuration and second Controllably switch between setting.In the first configuration, difunctional anode 824 and first stimulates cathode 832 to rise as described above Effect.In the second configuration, the polarity of difunctional anode 824 and stimulation cathode 832 is reversed.First configuration and the second configuration Between switching can compensate between the median nerve 488 of different user and ulnar nerve 890 be spaced (i.e. distance) variation.With narrow Wrist and therefore may want to the first configuration of selection with the user being spaced between smaller nerve.Simultaneously with wide wrist And the second configuration of selection therefore is may want to the user being spaced between larger nerve, wherein due to larger between nerve Interval, the second stimulation cathode 836 can closer to ulnar nerve 890, (wherein difunctional anode 824 keeps ratio than stimulation anode 878 First stimulates cathode 832 closer to median nerve 488).

In some embodiments, stimulation anode 878 is also difunctional, and is similar to difunctional anode 824, can be with It is used to both stimulate and monitor.Compared with the monitoring for using only one anode to realize, difunctional anode 824 and stimulation sun are used The monitoring that both pole 878 is realized can lead to improved ECG signal, this is because the anode external surface with wrist skin contact Product increases (i.e. compared with the external surface area of difunctional anode 424, outside the combination of difunctional anode 824 and stimulation anode 878 Portion's surface area).

In some embodiments, wearable element 400,700 and 800 can be around the middle section of forearm or forearm Proximal part is worn, such as to realize the nerve modulation of median nerve and/or ulnar nerve in forearm.In some embodiments, Wearable element can surround upper arm and wear, such as to realize the nerve modulation of median nerve and/or ulnar nerve in upper arm.One In a little embodiments, wearable element can be elasticity and can be adjusted to be worn around any part of arm, such as To realize nerve modulation as described above.In some embodiments, wearable element can surround leg for example around thigh It wears, such as to induce the nerve modulation of one or more peripheral nerves in leg.In some embodiments, wearable element 400, it 700 and 800 can be worn around the leg or neck of user, to realize wherein neural nerve modulation.

The another embodiment of present disclosure is schematically depicted in Fig. 9 a-9b.Fig. 9 a and Fig. 9 b are according to some Embodiment respectively schematically depicts the front view and rearview of smartwatch 900.Smartwatch 900 includes having preceding table The table body 910 in face 914 and rear surface 918.Table body 910 includes computing unit --- it includes processor and memory --- and electricity Pond (is not shown).Smartwatch 900 further comprises with the watchband 920 with outer surface 924 and with inner surface 928.Preceding table Face 914 includes wrist-watch user interface 932, such as touch screen (it also works as display).

Smartwatch 900 includes the intelligent object 950 of embedded watchband 920.Intelligent object 950 provides the reality of module 100 Example embodiment.In some embodiments, help in the module slot (not shown) being easily mounted on watchband 920 and from For it is removed, intelligent object 950 is modular.In some embodiments, module slot is configured as being adapted to different intelligence Energy module, to allow user to be exchanged between intelligent object as needed.Intelligent object 950 includes its outer surface (unnumbered) On monitoring electrode --- monitoring cathode 954 and its inner surface (unnumbered) on bifunctional electrodes --- difunctional anode 958 --- with stimulating electrode --- stimulation cathode 962.The outer surface (unnumbered) of cathode 954 is monitored on band outer surface 924 It is exposed.The outer surface (unnumbered) of difunctional anode 958 and the outer surface (unnumbered) of stimulation cathode 962 are with interior table It is exposed on face 928.

Smartwatch 900 is configured as surrounding the weared on wrist of user, so as to difunctional anode 958 in wrist just Middle nerve positioning, watchband 920 can be fastened and be tightened, such as in the interior section of wrist and difunctional anode 958 and thorn Skin contact is established between sharp cathode 962.In some embodiments, wrist is left finesse.Advantageously, with stimulation right finesse phase Than stimulation left finesse can provide the effect of stimulation of enhancing, this is because left median nerve and vagal anatomical physiology Relationship.

Intelligent object 950 includes control unit, monitoring unit and stimulating unit (not showing).Monitoring unit is single with control Member is associated with and is controlled by control unit, and is further associated with monitoring cathode 954 and is selectively closed with difunctional anode 958 Connection.Stimulating unit is associated with control unit and is controlled by control unit, and is further selectively closed with difunctional anode 958 Connection, and be associated with stimulation cathode 962.Control unit is controlled by the computing unit in table body 910 and is configured as sending letter It ceases computing unit and receives information from computing unit.Module 950 can be controlled thus by wrist-watch user interface 932.Tool For body, wrist-watch user interface can show cardiac parameters and ECG readings (ECG readings 990).

In some embodiments, device disclosed herein and method can be used to predict, prevent and treat angiocarpy Pathology.More specifically, in the monitoring pattern for the embodiment being mentioned above, HR/HRV or the ECG measurement repeated can give User indicates deterioration and the prediction cardiovascular event of nerve-heart balance.For example, LF or LF/HF than unexpected depreciation may be Patient with AF medical histories implies auricular fibrillation (AF) breaking-out that will be fallen ill.By operating stimulus modality, HR and HRV ginsengs Number can improve, thus prevent AF breaking-outs.In addition, planned prophylactic treatment can be utilized with stimulus modality.And And above mentioned embodiment can be used during the starting stage of cardiac event, offer can be proved to be to pass It is important in complex treatment --- for example within the hospital --- instant Primary Care before.Above mentioned embodiment may be used also Be used to improve cardio-vascular parameters after cardiovascular surgery or event.For example, the HRV reduced after myocardial infarction can be solved Parameter is to improve long-term surviving, (referring to above in invention content) such as referred to by EU and US heart associations.In addition, certain hearts After vascular surgery, the planned stimulation protocol applied by above mentioned embodiment can be carried out.For example, can solve The front and back HRV reduced of the resection operation of arrhythmia cordis, thus possibly improve the result of operation.

(ventricular extrasystole, also referred to as " room property premature shrinkage " (VPC) (such as pass through Fig. 5 a and 5b to arrhythmia cordis such as VPB In second generation prototype show)), APB (atrial premature beats, also referred to as " room too early compound sign " (APC)), PAF (paroxysms Property auricular fibrillation), CAF (Chronic Atrial Fibrillation), PsAF (permanent atrial fibrillation), SVT (supraventricular tachycardia) and room Tachycardia can benefit from monitoring and the stimulation ability of above mentioned embodiment.It can also solve other cardiovascular disorders Such as Coronary blood flowing, myocardial contraction obstacle (such as heart failure) and the hypertension (high blood) of reduction.

In module and wearable element (such as module 100 and 300 and wearable element 400,700 and 800, and intelligent hand Table 900) some embodiments in, the radius of electrode can be in about 1mm to the range of about 10mm, and according to some Embodiment, about 4mm are to about 6mm.It is respectively provided with the distance between the adjacent electrode of opposite polarity, such as via adjacent electrode Quantitative (on the same surface, such as inner surface 114 or inner surface 414) in the distance between respective center can be big In the range of about 3mm to about 30mm, according to some embodiments, about 15mm is to about 25mm, or even about 18mm is extremely About 22mm.In module and wearable element (such as module 100 and 300 and wearable element 400,700 and 800, and intelligence Wrist-watch 900) some embodiments in, radius of the electrode with about 3-10mm and the adjacent electrode with opposite polarity it Between distance can be in the range of 10 to 20mm.

In some embodiments, electrode can be square, oval or any other common or conventional shape, have place Size in the range similar to above mentioned range and surface area.

The size of electrode can change according to the target body portion that electrode is placed.Thus, in module and wearable member In some embodiments of part (such as module 100 and 300 and wearable element 400,700 and 800 and smartwatch 900), Change except the range that the size and the distance between surface area and electrode of electrode can be mentioned above.

In module and wearable element (such as module 100 and 300 and wearable element 400,700 and 800, and intelligent hand Table 900) some embodiments in, in this second mode of operation via pathway (one or more) conduct electric current (one It is a or multiple) it can be in 10 μ Α (i.e. microampere) to 5A, and preferably in the range of 100 μ Α to 500mA (i.e. milliampere). In preferred embodiment, electric current can be in the range of 1mA to 15mA.Electricity for nerve modulation median nerve and ulnar nerve The frequency of stimulus signal can be in 0.05Hz to 1000Hz, and preferably in the range of 0.25Hz to 100Hz.As made herein , term " intelligence is worn " and " intelligent band " also refer to wearable electronic device.

Referring now to Figure 10, it schematically depicts the box of monitoring and therapy devices 1000 according to some embodiments Figure.In some embodiments, device 1000 includes controller, such as control circuit 1010, configures cardiac monitoring in order to control Unit such as ECG monitoring unit 1050 and the such as electro photoluminescence of stimulation induction unit induce unit 1040.In some embodiments, ECG monitoring unit 1050 is connected to monitoring electrode such as ECG electrode 1020, and also passes through switching element such as switch 1092 It is connected to bifunctional electrodes 1024.In some embodiments, electro photoluminescence induction unit 1040 is connected to stimulating electrode 1032, and bifunctional electrodes 1024 are also connected to by switch 1092.

In some embodiments, control circuit 1010 is also connected to switch 1092 with controllably switching bi-functional electricity Pole 1024 induces the connection of unit 1040 to ECG monitoring unit 1050 or electro photoluminescence.In some embodiments, control element 1010, which are configured to supply instruction/signal enables to/, connects electro photoluminescence induction unit 1040 and control switch 1092, with even It connects bifunctional electrodes 1024 to electro photoluminescence and induces unit 1040, be enable to/originate stimulus modality, wherein electrical stimulation unit 1040 are configured as driving current or induction potential difference between stimulating electrode 1032 and bifunctional electrodes 1024.

In some embodiments, control circuit 1010 be further configured to provide instruction/signal enables to/connect Logical ECG monitoring unit 1050 and control switch 1092, to connect bifunctional electrodes 1024 to ECG monitoring unit 1050, to make Can/starting monitoring pattern, wherein ECG monitoring unit 1050 is configured as from ECG electrode 1020 and bifunctional electrodes 1024 Obtain electric (difference-electricity) signal.

Referring now to Figure 11, it schematically depicts the method treated and monitored for recurrence according to some embodiments 1100.In some embodiments, method 1100 originates in cardiac parameters (one or more) (step 1102) of monitoring user, Then target/target of analysis of cardiac parameter (one or more) (step 1103) and determination/setup parameter (one or more) (step 1104) and provide stimulation (step 1106) based on determining target.Then, cardiac parameters are monitored again after stimulation (one or more) (step 1108), and with the target of the determination of the parameter of monitoring (one or more) and previous value ratio Compared with parameter (one or more) (step 1110) that analysis monitors recently.According to analysis, new target can be set, or can be with Stimulation parameter is changed to realize target.

According to some embodiments, monitoring and therapy devices include/machine learning algorithm is utilized, to study many kinds of parameters Under certain conditions to the response of stimulation, and reorganization incentive condition is preferably to meet the target for the treatment of in future/stimulation-period.

According to some embodiments, based on the measurement change stimulation parameter and item carried out before the stimulation period previous Part, thus carry out closed circuit stimulation and adjust cycle, to obtain the effect of desired.According to some embodiments, system Closed loop cycle may include stimulation, measures, send to measure and analyze computer, analyze data and adjust accordingly stimulation item Part/parameter sends back measurement and stimulating apparatus and provides stimulation using the parameter adjusted.

According to some embodiments, monitoring and therapy devices include error correction unit or for correcting in monitoring unit The algorithm of measurement error.

The certain features for understanding the present invention describe in order to clear under the background of individual embodiment, can be in list It combines and provides in a embodiment.On the contrary, multiple features of the present invention, in order to succinctly be retouched under the background of single embodiment It states, it can also be in any other embodiment of the present invention individually or with any appropriate sub-portfolio or by suitably carrying For.The feature described under the background of embodiment is not considered as the essential feature of the embodiment, unless clearly this Control gauge is fixed.

Although the inventive step according to some embodiments can be described in a particular order, the method for the present invention can To include the steps that some or all of in the description implemented with different order.The method of the present invention may include being described It is only several in the step of step or description.Specific steps in disclosed method are not considered as the steps necessary of method, are removed Non-clearly it is specified that.

Although describing the present invention together with its specific embodiment, apparent there may be to those skilled in the art Clear numerous alternative solutions, change and modification.Therefore, the present invention cover fall within the scope of the appended claims it is all this Alternative solution, change and the modification of sample.Understand that the present invention not necessarily limits its application to the construction for the component stated herein With arrangement and/or the details of method.Other embodiment can be put into practice, and embodiment can be carried out in many ways.

The wording and term used herein for the purpose of description and is not construed as restrictive.It is any in the application The reference or identification of bibliography are not construed as recognizing the prior art that such bibliography can be used as the present invention.Column Target topic be used to be readily appreciated that specification and is not construed as inevitable restrictive herein.

Claims

1. for monitoring object one or more cardiac parameters and Noninvasive electric nerve-stimulation object it is one or more The portable module of peripheral nerve comprising：

Electrode is monitored, be mounted in the top surface of the portable module/on；

Stimulating electrode and bifunctional electrodes, be mounted in the bottom surface of the portable module/on；

Monitoring unit for monitoring electrical activity；

Stimulating unit for inducing electric signal；With

Control unit；

Each in the wherein described electrode is at least partly exposed；

Wherein be configured such that can between at least two operation modes of the portable module for described control unit The switching of control ground：

First mode, wherein the monitoring unit and the monitoring electrode and bifunctional electrodes function association；With

Second mode, wherein the stimulating unit and the stimulating electrode and bifunctional electrodes function association；

The wherein described module is configured as contributing between the target body portion and the bifunctional electrodes of the object, with And skin contact is established simultaneously between the opposite body part and the monitoring electrode of the target body portion, to permit Perhaps, in the first mode, the object is obtained by monitoring the electrical activity at the bifunctional electrodes and monitoring electrode Cardiac parameters；And

The wherein described module is further configured to contribute in the target body portion and the bifunctional electrodes and described Stimulating electrode establishes therebetween skin contact, to allow, in the second mode, by the bifunctional electrodes and At least one of target body portion peripheral nerve described in electric signal electrical nerve stimulation is induced between stimulating electrode.

2. module described in claim 1, wherein one or more cardiac parameters include heart rate and/or heart rate variability (HRV)。

3. the module described in any one of preceding claims, wherein the monitoring unit is configured for the heart of the object Electrography (ECG).

4. the module described in any one of preceding claims, wherein the module is configured as being directed to the target body portion Independently kept.

5. the module described in any one of preceding claims, wherein the target body portion be wrist, arm, forearm, leg or The interior section of neck.

6. the module described in claim 5, wherein at least one peripheral nerve is the center in the wrist, arm or forearm Nerve.

7. the module described in any one of preceding claims, wherein the stimulating electrode is the first stimulating electrode and wherein described Stimulus signal is the first stimulus signal；

The module further comprises being mounted in the bottom surface/on the second stimulating electrode, such as by sudden and violent at least partly Reveal and so that the bifunctional electrodes position between first stimulating electrode and second stimulating electrode；And

The wherein described module is further configured to contribute between the target body portion and second stimulating electrode Skin contact is established, to allow, in the second mode, between the bifunctional electrodes and second stimulating electrode The second stimulus signal is induced, optionally either simultaneously or alternately with first stimulus signal, to target described in electrical nerve stimulation At least one peripheral nerve in body part.

8. module according to any one of claims 1 to 6, wherein the stimulating electrode is the first stimulating electrode and wherein described Stimulus signal is the first stimulus signal；The module further comprise be mounted on the bottom surface in/on the second stimulating electrode It with third stimulating electrode, for example is at least partly exposed, wherein first stimulating electrode, the bifunctional electrodes, described Third stimulating electrode and second stimulating electrode are substantially linearly arranged respectively；And

The wherein described module is further configured to contribute in the target body portion and second stimulating electrode and the Skin contact is established between tristimulus electrode, to allow, in the second mode, in the third stimulating electrode and described The second stimulus signal is induced between second stimulating electrode, optionally either simultaneously or alternately with first stimulus signal, to electricity The second peripheral nerve in target body portion described in nerve stimulation.

9. module according to any one of claims 8, wherein the target body portion is the interior section of wrist and at least one Peripheral nerve is the median nerve in the wrist, and wherein described second peripheral nerve is in the wrist, arm or forearm Ulnar nerve.

10. the module described in any one of preceding claims, wherein the stimulus signal is by being based in the first mode The stimulation parameter characterization that the cardiac parameters obtained determine.

11. module according to any one of claims 10, wherein the stimulation parameter is selected from：The frequency of voltage signal and/or current signal, Intensity, amplitude, duration, waveform, intermittence and polarity.

12. the module described in any one of preceding claims, wherein the module is modular, such as to allow can remove Ground is attached to wearable device.

13. the module described in claim 12, wherein the wearable device is intelligence band or smartwatch comprising processing electricity Road, and the wherein described module and the wearable device are function associations.

14. the module described in claim 13 is further configured to be controllable via the user interface of the wearable device 's.

15. the module described in any one of claim 13 and 14, wherein the monitoring electrode is in the outer of the wearable element It is at least partly exposed on surface, and the wherein described bifunctional electrodes and stimulating electrode are in the interior table of the wearable element It is at least partly exposed on face.

16. wearable device comprising the module described in any one of claim 1 to 11, and be configured to surround the object Limbs or neck wear band, the band have the inner surface and the outer surface；

The wherein described monitoring electrode is at least partly exposed on the outer surface and the bifunctional electrodes and stimulation are electric Pole is at least partly exposed on the internal surface；And

The wherein described target body portion positions in the limbs or the neck.

17. the wearable device described in claim 16, wherein described, to bring a step into include user interface, is configured to contribute to Control the operation of the module.

18. the wearable device described in claim 17, wherein the user interface includes display, it is configured to provide for and institute State the relevant figure instruction of operation of module.

19. the wearable device described in claim 18, wherein figure instruction includes obtaining in the first mode The cardiac parameters and/or the stimulation parameter obtained in the second mode.

20. the wearable device described in claim 19, wherein the user interface is configured as during the second mode Show the ECG/HR/HRV readings of the object.

21. the wearable device described in any one of claim 16 to 20 further comprises for providing electric power to maintain it The battery of operation.

22. the method for requiring the wearable device described in any one of 12 to 21 for operational rights comprising following step：

The wearable element is fastened around the wrist of object, forearm, arm, limbs, leg or neck, so as to the stimulating electrode and institute State the interior section skin contact of bifunctional electrodes and the wrist, wherein the bifunctional electrodes in the wrist just Middle nerve and/or ulnar nerve positioning；

It selects the first operator scheme and opposite body part is made to be contacted with the monitoring electrode；

By monitoring electrical activity between the monitoring electrode and the bifunctional electrodes, the heart correlation for measuring the object is lived It is dynamic, and cardiac parameters are determined by it；

Stimulation parameter is determined based on the cardiac parameters；With

The second operator scheme is selected, and by generating stimulation letter between the stimulating electrode and the bifunctional electrodes Number, apply electro photoluminescence at the interior section of the wrist.

23. the method described in claim 22, further comprises, the selection second operator scheme the step of after, The step of reapplying the selection first operator scheme measures the heart-related activity, and determines the stimulation ginseng Therefore number, to obtain newer cardiac parameters, and adjusts the stimulation parameter.